Psychological Stress and Support Needs of Volunteer First Responders After Smartphone-based Cardiac Arrest Alerts
NCT07607808
Behavior, Behavioral Symptoms
Aachen, North Rhine-Westphalia, Germany
View Trial DetailsNCT Number: NCT06886841
Improving maternal and child health is a global priority, with increasing emphasis on ensuring women and their families not only survive but also thrive after childbirth. While high-income countries like Switzerland provide strong antenatal and intrapartum care, the quality of postnatal care often lags behind, despite the critical physical, mental, and social needs of the postpartum period. Studies indicate high rates of mental distress, physical pain, and sexual discomfort among mothers, alongside a lack of research on the well-being of co-parents.
The main question this cohort study aims to answer is: how do the health and well-being of mothers and co-parents evolve during the first year after childbirth? Participants will complete four online questionnaires: the first within the first few days after birth, followed by additional assessments at 2, 6, and 12 months postpartum.
This comprehensive approach seeks to inform policy and improve evidence-based postnatal care practices, benefiting approximately 80,000 families annually in Switzerland.
Interested in participating?
Request Info14 year and older
All sexes
Observational
Haute Ecole de Santé Genève, Geneva, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 months postpartum
The prevalence of childbirth-related post-traumatic stress disorder in both parents will be assessed using the validated City Birth Trauma Scale (City BiTS). This self-reported questionnaire consists of 29 items, 20 of which measure the frequency of trauma symptoms, including intrusive thoughts, avoidance, negative mood, and hyperarousal, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Items are rated using a four-point Likert-type scale, ranging from 0 to 3. The total score varies from 0 to 60 points, with higher scores indicating a higher level of PTSD-symptoms.
Time frame: At birth, and at 2, 6, and 12 months postpartum
Postpartum depression and anxiety will be assessed in both parents, using the Edinburgh Postnatal Depression Scale (EPDS) at birth, and at 2, 6, and 12 months postpartum. This validated 10-item questionnaire screens for symptoms of depression and anxiety. Responses are rated on a four-point Likert scale, ranging from 0 to 3. The total score ranges from 0 to 30 points, with higher scores indicating a greater risk of depression.
Time frame: At birth, and at 2, 6, and 12 months postpartum
Assessed in both parents with the EuroQoL 5-Dimension 5-Level scale (EQ-5D-5L), along with a visual analogue scale for self-rated health (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a visual analogue scale ranging from 0 to 100 where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time frame: At birth (Obstetric Quality of Recovery-10), and at 2, 6, and 12 months postpartum (pain and incontinence)
Mothers' quality of recovery after childbirth, will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) tool. This validated, self-reported measure evaluates pain, physical symptoms, mobility, self-care, and baby care on an 11-point scale ranging from 0 (worst outcome) to 10 (best outcome). The total score ranges from 0 to 100, with higher scores indicating better recovery quality. Additional dimensions, in particular pain and incontinence, will also be evaluated in mothers.
Time frame: 6 and 12 months postpartum
Assessed at 6 and 12 months postpartum in mothers using the Female Sexual Function Index (FSFI-6), a validated questionnaire that can be used to screen for sexual dysfunction in women. It consists of 6 items covering 6 domains (desire, arousal, lubrication, orgasm, satisfaction, and pain). Each item of the FSFI-6 questionnaire is associated with a 5-point ordinal scale, in which 5 represents optimal function and 1 the poorest function. The scores for each domain are summed to provide a total score, with a higher score indicating better sexual function.
Time frame: From one year before to one year after childbirth
Collected through linkage with the "Medical Statistics of Hospitals" database, this outcome includes the frequency, reasons, and costs of hospitalisations from one year before to one year after childbirth. This data provides critical insights into severe health outcomes and rehospitalisations in mothers and infants.
Contact information is provided by the study sponsor or research team.
Elsa Lorthe, PhD
CONTACT
Laurent GAUCHER, PhD
CONTACT
Laurent Gaucher
Other
Stress Of Co-parents Related to A Traumatic Experience of Birth Across Switzerland
Acronym: SOCRATES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07607808
Behavior, Behavioral Symptoms
Aachen, North Rhine-Westphalia, Germany
View Trial DetailsNCT07477314
Access to Recommended Healthcare, Behavior
Bordeaux, France
View Trial DetailsNCT07452900
Anxiety, Anxiety Disorders
Waco, Texas, United States
View Trial DetailsNCT01037946
Behavior, Family Relations
Los Angeles, California, United States
View Trial Details